Retractor for vaginal repair

ABSTRACT

A self-expanding retractor is described for placement within the vaginal canal of a post-partum female to aid in performing a vaginal repair. The retractor provides improved exposure and enhanced visualization of an episiotomy or vaginal laceration repair site. The retractor is typically in the form of a foldable, trapezoidal frame defining a central aperture, and includes anterior stability posts at its corners and a panel spanning the central aperture. The panel is typically in the form of a surgical gauze pad for absorbing blood and fluids entering the surgical field. The retractor can be folded by a user for placement within the vaginal canal and then released, which allows it to expand to hold back swollen tissues from obstructing the repair site. The retractor is typically lightweight and compact and is configured to minimize slippage during use.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of U.S. application Ser. No.16/354,597 filed Mar. 15, 2019, the disclosure of which is herebyincorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates generally to obstetric surgicalinstruments, and more particularly to a retractor which providesimproved exposure for working about the perineum and vaginal walls of apost-partum patient.

BACKGROUND OF THE INVENTION

Lacerations of the vaginal walls and the perineum commonly occur duringvaginal delivery. In addition, sometimes an episiotomy, i.e. a surgicalcut made at the vaginal opening, is made by a health care professionalsuch as an obstetric surgeon or midwife to enlarge the vaginal openingduring childbirth. Typically an episiotomy is made through the posteriorvaginal wall and the perineum, i.e. between the vaginal opening and theanus. Although an episiotomy was once common practice, due to theincreased risk of infection and other complications the currentrecommendations are to perform such an incision only when necessary.Therefore, an episiotomy will typically only be performed to aid adifficult delivery or to prevent rupture of tissues. Nevertheless, evenwhen an episiotomy is not performed, vaginal delivery may still causestretching, tearing and lacerations of the vaginal walls and perineum,which will need to be repaired.

An episiotomy incision or vaginal laceration should be repaired promptlyfollowing childbirth to reduce blood loss and prevent infection. Thehealth care professional will initially examine the tissues to determinethe extent of repair needed, and repair of the incised or laceratedtissues is then typically performed by placement of sutures, whichabsorb over time. Adequate pain relief should be provided beforesuturing, and this is typically done via injection of a local anestheticinto the skin and muscle in and around the surgical area to numb thetissues.

Typical prior art vaginal retractors are speculum-type retractors, inwhich a pair of metal blades are connected to a body with handles foropening and closing the blades. The blades are typically smooth and thinmetal plates with dull edges that are inserted into the vaginal canaland then opened to pull back the tissue. In use, the blades are firstplaced into a closed position in which they are in close proximity toone another for insertion into the vaginal canal, and the blades arethen displaced by the handles to assume an open position which spreadsapart the tissues. Such retractors are typically useful for performingpelvic examinations on non-laboring females, but they can also be usedto create a surgical workspace for post-partum laceration repair.

While useful, prior art bladed or speculum-type vaginal retractors havenot proven to be entirely satisfactory for post-partum lacerationrepair. For example, the delivering mother's labia typically areengorged and swollen as compared to a non-parturient female, andstandard bladed retractors are generally not satisfactory because theswollen labia can expand around the blades and impinge on the field ofvision, making the repair more difficult. In addition, the metal bladesand their handles can be cold and heavy, and, since the handlestypically suspend externally from the vagina during the repair, theirweight can cause the retractor to slip or displace. In addition, theexternally suspended handles often obstruct the range of movement of thesurgeon, causing the sutures to become entangled about the handles.Bladed retractors are also difficult to use if there is a laceration ofthe vaginal side wall or sulcus, since in practice the blades aretypically inserted against the side walls of the vagina prior to openingthe blades. As a result the blades must be manipulated or even removedin order to gain access to the laceration and finish the repair. Suchlimitations of an already difficult and bloody work area generally makesrepair more difficult and time-consuming, leading to increased bloodloss, incomplete repair, and infection.

In addition to the physical limitations noted above when usingspeculum-type retractors for post-partum laceration repair, the limitedexposure they do provide is often distorted or clouded by inflowingblood and other fluids entering the surgical field from the cervix anduterus, which is common following vaginal delivery. As a result, thesurgeon will often place a gauze pad or a surgical sponge into thevagina during the repair procedure in order to absorb these fluids andimprove visualization. However, secondary sponge placement can also leadto complications, such as entanglement of the sponge with the retractoror the sutures. In addition, there is the potential that the sponge,which is not attached to the retractor, can be inadvertently left insidethe vagina after the repair, creating a nidus for infection.

In view of the above discussion, it is apparent that there is a need inthe obstetric surgical arts to provide an improved apparatus and methodfor performing a post-partum vaginal laceration or episiotomy repair. Itwould therefore be advantageous to provide a vaginal retractor whichimproves access and visualization of the repair site, is configured tominimize slippage during use, and which is lightweight and minimizesdiscomfort to the patient. It would also be advantageous to provide avaginal retractor with a means to absorb or prevent blood and otherfluids entering the surgical field. It would also be beneficial toprovide a vaginal retractor which can be utilized by health careprofessionals having various skill levels.

SUMMARY OF THE INVENTION

Briefly stated, a retractor for vaginal repairs according to thedifferent embodiments of this invention can provide sufficientvisualization of lacerated tissues of the post-partum perineum andvaginal walls.

One aspect of the invention provides a retractor for use in performing arepair of a vaginal laceration, the retractor comprising: (a) a foldableframe defining a central aperture and including an upper support, alower support, a right lateral support, a left lateral support, a rightupper anterior stability post, a left upper anterior stability post, aright lower anterior stability post, and a left lower anterior stabilitypost; and (b) a compliant panel spanning the central aperture, whereinthe frame is biased to assume an open position, can be folded by a userinto a closed position for insertion into the vaginal canal, and canthen return to the open position after release by the user.

Another aspect of the invention provides a retractor for performing arepair of a vaginal laceration, the retractor comprising: (a) a foldableframe defining a central aperture, the frame including: (i) an uppersupport including a central upper crimp; (ii) a lower support includinga central lower crimp, wherein the central upper crimp and the centrallower crimp are biased to bend when a force is applied by a user and tostraighten when the force is released; (iii) a right lateral support;(iv) a left lateral support, wherein the upper support, the lowersupport, the right lateral support, and the left lateral support areconnected to form the frame defining the central aperture; (v) a rightupper anterior stability post; (vi) a left upper anterior stabilitypost; (vii) a right lower anterior stability post; and (viii) a leftlower anterior stability post; and (b) a compliant panel spanning thecentral aperture, wherein the frame is biased to assume an openposition, can be folded by a user into a closed position for insertioninto the vaginal canal, and can then return to the open position afterrelease by the user.

Another aspect of the invention provides a method of performing a repairof a vaginal laceration, the method comprising the steps of: (a)providing a vaginal retractor, the retractor comprising: (i) a foldableframe defining a central aperture and including an upper support, alower support, a right lateral support, a left lateral support, a rightupper anterior stability post, a left upper anterior stability post, aright lower anterior stability post, and a left lower anterior stabilitypost, wherein the frame is biased to assume an open position; and (ii) acompliant panel spanning the central aperture; (b) folding the frameinto a closed position; (c) inserting the frame into the vaginal canal;(d) releasing the frame to expand to the open position within thevaginal canal; and (e) repairing the vaginal laceration by suturing thelacerated tissue layers.

Another aspect of the invention provides a retractor for gynecologicalprocedures involving the lower internal genital organs, the retractorcomprising: (a) a frame defining a central aperture, the frame includingan upper support, a lower support, a right lateral support, a leftlateral support, a right upper anterior stability post, a left upperanterior stability post, a right lower anterior stability post, and aleft lower anterior stability post, wherein the frame is biased toassume an open position in which the supports are oriented substantiallyin a single plane, and wherein each of the anterior stability postsextend substantially perpendicularly from the plane of the open frame;and (b) a plurality of walls for restraining vaginal tissues fromobstructing the central aperture, wherein each of the plurality of wallsis connected to the frame and extends substantially perpendicularly fromthe plane of the open frame, and wherein the frame can be folded into aclosed position for insertion into the vaginal canal.

Another aspect of the invention provides a retractor for gynecologicalprocedures involving the lower internal genital organs, the retractorcomprising: (a) a frame defining a central aperture, the frameincluding: (i) an upper support including a central upper crimp; (ii) alower support including a central lower crimp, wherein the central uppercrimp and the central lower crimp are biased to bend when a force isapplied by a user and to straighten when the force is released; (iii) aright lateral support; (iv) a left lateral support, wherein the uppersupport, the lower support, the right lateral support, and the leftlateral support are connected to form the frame defining the centralaperture; (v) a right upper anterior stability post; (vi) a left upperanterior stability post; (vii) a right lower anterior stability post;and (viii) a left lower anterior stability post; wherein the frame isbiased to assume an open position in which the supports are orientedsubstantially in a single plane, and wherein each of the anteriorstability posts extend substantially perpendicularly from the plane ofthe open frame; and (b) a plurality of walls for restraining vaginaltissues from obstructing the central aperture, wherein each of theplurality of walls is connected to and extends substantiallyperpendicularly from the plane of the open frame, the plurality of wallscomprising: (i) a right side wall located between the right upperanterior stability post and the right lower anterior stability post;(ii) a left side wall located between the left upper anterior stabilitypost and the left lower anterior stability post; and (iii) an upper walllocated between the right upper anterior stability post and the leftupper anterior stability post, wherein the frame can be folded into aclosed position for insertion into the vaginal canal.

The nature and advantages of the present invention will be more fullyappreciated after reviewing the accompanying drawings, detaileddescription and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate embodiments of the invention and,together with a general description of the invention given above, andthe detailed description given below, serve to explain the principles ofthe invention.

FIG. 1 is a frontal view of one embodiment of the inventive retractor;

FIG. 2 is a right lateral view of the retractor of FIG. 1;

FIG. 3A is a frontal view showing the retractor of FIG. 1 when in thecollapsed position;

FIG. 3B is a side view of the collapsed retractor of FIG. 3A laying onits back;

FIG. 4 is a perspective view of the inventive retractor of FIG. 1positioned within the vagina of a patient with a vaginal laceration;

FIG. 5 is a frontal view of a further embodiment of the inventiveretractor;

FIGS. 6A-6E illustrate various curvature orientations of the upper andlower supports of the inventive retractor;

FIG. 7 is a frontal perspective view of an alternative embodiment of theinventive retractor having 3 side walls;

FIG. 8 is a frontal perspective view of an alternative embodiment of theinventive retractor having four side walls.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, terms such as laceration, tear, cut, incision,“lacerated tissues”, “vaginal laceration” or “episiotomy incision”,although technically different in nature and created in different ways,are understood to be interchangeable.

As used herein, terms such as fold, foldable, folded, collapse,collapsible and collapsed are understood to be interchangeable whenreferring to either the upper and lower supports or the frame being in,or assuming, a “closed” position.

A preferred embodiment of the inventive retractor is illustrated inFIGS. 1, 2, 3A and 3B, which show a foldable frame 12. The frame 12 isbiased or predisposed to take an expanded or “open” position as shown inFIGS. 1 and 2, but can be folded or otherwise manually compressed orcollapsed by a user into a “closed” position as shown in FIGS. 3A and3B. Looking at FIGS. 1 and 2, both the upper support 13 and the lowersupport 15 include a bendable central crimp, 14 and 16, respectively.More specifically, the central upper crimp 14 and the central lowercrimp 16 bend when a force is applied by a user, and they straightenwhen the force is released. The central upper crimp 14 and the centrallower crimp 16 are preferably made of a semi-rigid but flexible plasticmaterial, so while biased to assume a substantially straight or unfoldedorientation, they can be caused to bend when a manual force is appliedby a user. Such an applied force can bend the crimps 14, 16 so thattheir corresponding upper and lower supports 13, 15 fold in uponthemselves, causing the frame 12 to fold as well, assuming the closedposition as illustrated in FIGS. 3A and 3B. When the force is removed,i.e. by releasing the frame, the crimps 14, 16 will then straighten outand the retractor re-expands to the “open” position.

The frame 12 is preferably intended to be positioned within theintroitus, or entrance, of the vaginal canal, or slightly deeper intothe vaginal canal if needed, to provide improved exposure and access tothe surgical field, and is typically folded into the closed positionprior to and during insertion into the vaginal entrance. Once insertedand released, the frame 12 will expand on its own assume the openposition. The frame 12 is defined by an upper support 13, a lowersupport 15, a right lateral support 17, and a left lateral support 19.The supports 13, 15, 17 and 19 are preferably connected at their ends toform a trapezoidal-shaped frame 12 defining a central aperture 20 withinits inner perimeter.

As best seen in FIG. 1, when the frame 12 is in its biased “open”position, the supports 13, 15, 17, 19 are oriented substantially in asingle plane and the central aperture 20 is substantially filled by apanel 20. The panel 20 is typically attached to or otherwise secured tothe frame, substantially spanning the central aperture, and ispreferably compliant with the frame, i.e. it is generally thin andflexible and acquiesces or yields to the opening and closing movementsof the frame. The panel 20 aids the user in visualization of thesurgical field, i.e. the lacerated vaginal and perineal tissues of thepost-partum mother (see FIG. 4), by absorbing or otherwise avertingfluids from entering. In a preferred embodiment the panel 20 is anabsorbent pad made of cotton, surgical gauze, a surgical sponge or othersimilar compliant and semi-permeable material useful for substantiallyabsorbing blood and other fluids passing through the central aperture.In another embodiment (not shown) the panel can be made of a plasticmembrane, net or other similar substantially non-permeable materialuseful for preventing entrance/passage of blood and other fluids throughthe central aperture.

In a preferred embodiment the retractor frame 12 and the panel 20 aremanufactured together, such that the panel comes pre-installed and spansthe central aperture of the frame. In this manner, the retractor isready to use without additional steps needed to load the panel into theretractor frame prior to use. The panel can also be manufactured toenvelope the frame or be stretched around the supports 13, 15, 17 and19. In one embodiment a second panel (not shown), in the form of eithera semi-permeable material such as an absorbent pad or a non-permeablematerial such as a plastic membrane, can be secured to the frame alongwith the initial panel. Inclusion of a second panel may be useful forimproved visibility, should the user anticipate oversaturation of thesurgical field with blood or fluids from the vaginal canal during therepair procedure.

The frame supports 13, 15, 17 and 19 are typically rigid plasticstructures and are preferably connected at their corners to form aunitary, trapezoidal-shaped frame 12. Each of the four corners of theframe 12 have projections, specifically, a right upper anteriorstability post 40, a left upper anterior stability post 42, a rightlower anterior stability post 44, and a left lower anterior stabilitypost 46. The anterior stability posts 40, 42, 44, 46 are preferably madeof a rigid plastic like the frame supports, and extend substantiallyperpendicularly from the plane of the open frame 12. In contrast, thebendable central crimps 14 and 16 are necessarily less rigid in naturethan the frame supports and the anterior stability posts, and aretypically made of a soft plastic or elastomer which bends to allow theirrespective supports 13, 15 to be folded when a manual force is appliedby the user.

The frame supports 13, 15, 17, 19 and the anterior stability posts 40,42, 44, 46 function to support and retract the swollen tissues duringuse, so that the laceration 50 (see FIG. 4) can be visualized, accessed,and repaired. As seen in FIG. 2, the right and left upper stabilityposts 40, 42 can include a divot along their length to receive andsupport the pubic bone. The anterior stability posts 40, 42, 44, 46 inthe embodiment shown in FIGS. 1, 2, 3A and 3B are telescopic in nature,and function to retract and hold back the swollen labia and/or othervaginal tissues from interfering with visualization of the surgicalfield. In use, the telescopic posts can be manually shortened prior tofolding the frame into the closed position, and then extended out by theuser after the frame re-opens. The anterior stability posts' ability toextend out is useful for providing labial retraction; nevertheless, insituations in which the laceration 50 requires the retractor to beplaced deeper than normal within the vaginal canal, the anteriorstability posts may not be able to fully retract the labia, but they canstill support the labia to some degree as well as hold back the swollentissues within the vaginal canal to provide adequate visualization ofthe surgical field.

As can be seen in FIGS. 1, 2, 3A and 3B, each of the lateral supports17, 19 can include a set of stability ridges 30, typically in the formof a series of raised semi-circular edges protruding between about 1 mm(millimeters) to about 3 mm from the outer perimeter of the lateralsupports. The stability ridges 30 serve to hold the retractor in place,i.e. in its position within the vaginal canal, by virtue of the roughsurfaces created by the raised edges. They are included to counteractslippage of the frame during use by increasing the amount of frictionbetween the vaginal tissue and the retractor.

As illustrated in FIGS. 3A and 3B, bending of the flexible crimps 14, 16can cause the frame 12 to assume the closed position. Specifically, whena manual force is applied by the user to bend the crimps 14, 16, thecorresponding upper and lower supports 13, 15 fold in upon themselves.When the force is removed, i.e. by releasing the frame, the retractorre-expands to the “open” position illustrated in FIGS. 1, 2 and 4. Thecompliant panel 20, being made of a generally thin and flexiblematerial, folds along with the frame 12. As shown in FIGS. 3A and 3B, inthis closed position the right lateral 17 and the left lateral 19supports come into close proximity with each other, as do the upper 40,42 and lower 44, 46 anterior stability posts (which can be shortened, iftelescopic). This closed position easily allows for placement andpositioning of the collapsed retractor into the vaginal canal by theuser. Once the retractor is properly positioned, the user can releasethe retractor, allowing the crimps 14, 16 to straighten and return theframe to the “open” position (see FIGS. 1, 2 and 4).

While the crimps 14, 16 provide the frame 12 with the ability to befolded or collapsed into the closed position, it should be noted thatthe foldable retractor described herein is not limited to this means offolding. For example, rather than employing crimps, each of the cornersof the frame can be made of a semi-rigid but flexible plastic materialwhich allows the frame to be contorted or otherwise twisted at thecorners, causing the frame to collapse and/or fold into the closedposition. Alternatively, the corners may be constructed to be “hinged”in such a way that the frame collapses or folds into the closedposition.

FIGS. 4 and 5 illustrate an embodiment of the retractor frame havinganterior stability posts 70, 72, 74, 76 which are outwardly curved orotherwise biased in an outward direction. This curved design provides anadditional means to hold back swollen vaginal or labial tissues whichmay be entering the surgical field. Further, both FIG. 4 and FIG. 5illustrate an optional ring 24 attached to the frame by a string 26. Thering can aid in the retrieval of a lost or retained retractor, should itsomehow become dislodged and lost within the vaginal canal. The framesupports 13, 15, 17, 19 and/or the ring 24 can contain RFID scanningtechnology as is known in the art, which can be used to identify aretained product and aid in retrieval.

During use, and after being folded into the closed position and insertedat the entrance of the vaginal canal and behind the laceration site 50,the folded retractor frame is released by the user. The crimps 14, 16assume their original straight shape per their bias, and the framesupports 13, 15 expand, so that the retractor assumes the open position.Looking at FIG. 4, a typical surgical field amenable for using theinventive retractor includes an episiotomy incision/vaginal laceration50 located in the area including the posterior vaginal wall 64 and theperineum 68, i.e. the area of skin and muscular tissue between theposterior vaginal wall 64 and the anus 70. The frame 12 is placed by thesurgeon into the vaginal introitus, located beneath the pubic bone 52,the clitoris 54 and the urethral opening 56. The right and left upperanterior stability posts 70, 72 secure the frame between the right andleft anterior sulci 60, 62 of the anterior vaginal wall above, while theright and left lower anterior stability posts 74, 76 secure the framebetween the right and left posterior sulci 64, 66 of the posteriorvaginal wall below. This positioning serves to prevent slippage of theretractor frame within the vaginal canal during the repair procedure.After expansion, the retractor frame 12 is completely out of the way ofthe surgeon and provides the exposure needed for visualization of thelaceration and suture placement. In addition, the retractor's panel 20provides a barrier to blood and fluids flowing into the surgical field.

As seen in the embodiment illustrated in FIG. 5, the retractor can alsoinclude posterior stability posts 80, 82, 84, 86, which extend from theframe 12 in substantially the opposite direction as the anteriorstability posts 70, 72, 74, 76. Specifically, as shown in FIG. 5, theretractor frame can include a right upper posterior stability post 80, aleft upper posterior stability post 82, a right lower posteriorstability post 84, and a left lower posterior stability post 86respectively corresponding to the right upper anterior stability post70, the left upper anterior stability post 72, the right lower anteriorstability post 74, and the left lower anterior stability post 76. Theposterior stability posts are typically shorter than the anterior posts,but nevertheless can assist in retraction as well as prevent slippage orbackward movement of the frame within the vaginal canal.

The inventive retractor is intended to be of appropriate size and shapeto be placed within the vaginal introitus of a human or mammalianfemale, with the specific size needed being determined by the particularsubject. For example, in the open position the frame 12 may establish aperimeter of about 5 cm to about 40 cm, inclusive of all dimensionswithin this range. In a preferred embodiment, the lower support 15 andthe right and left lateral supports 17, 19 are substantially the samelength (e.g. 3-10 cm long), while the upper support 13 is shorter (e.g.1-7 cm long), so that the overall shape of the frame is trapezoidal whenin the open position. In the inventor's experience, this trapezoidalshape best fits the anatomy and natural contours created by the varioussupport ligaments, muscles, soft tissues and membranes forming thevaginal canal.

FIGS. 6A-6E illustrate various different configurations of atrapezoid-shaped retractor in the open position in which there arediffering orientations of the curve of the top and bottom supports 13,15. FIG. 6A shows the preferred embodiment shown in FIGS. 1 and 2 withthe upper support 13 having its central portion curved downward and thelower support 15 curved upward, while FIG. 6B shows both supports 13, 15having their central portion curved downward, FIG. 6C shows bothsupports 13, 15 having their central portion curved upward, FIG. 6Dshows the upper support 13 having its central portion curved upward andthe lower support 15 curved downward, and FIG. 6E shows both supports13, 15 having a straight orientation. Depending on the specific anatomyof the subject, these specific support curvatures can be used whilestill maintaining the general trapezoidal shape of the retractor toprovide an optimal fit within the vaginal canal.

The frame supports 13, 15, 17, 19 can be made of a hard rubber,semi-rigid plastic or hard plastic, while the crimps 14, 16 can be madeof a more flexible, elastic material such as silicone rubber, semi-rigidplastic or other elastomer. The “Shore A” or durometer hardness value ofthe supports 13, 15, 17, 19 is typically higher (i.e. harder) than thecrimps 14, 16, which are more elastic. As a non-limiting example, thecrimps can be of soft to medium hardness (e.g. 35-60 Shore A) so thatthey can be bendable but, as noted above, biased to returned to asubstantially straight configuration, while the supports are more rigidand can measure on the high end of the hardness scale (e.g. 75-100 ShoreA).

The stability posts 40, 42, 44, 46 are also rigid plastic structures onthe high end of the hardness scale (e.g. 75-100 Shore A), and they canbe attached to the frame by various means as is known in the art. Forexample, the stability posts can be manufactured along with the framesupports as a unitary frame structure, extending substantiallyperpendicularly from the frame at each of the corners. In otherembodiments, the stability posts can be screwed on, snapped on, orotherwise attached after being separately manufactured apart from theframe structure.

The panel 20, when in its preferred form of an absorbent pad, ispreferably made of surgical gauze. Surgical gauze is typically made fromfibers of cotton, rayon, polyester, or a combination of these fibers. Inthe U.S., surgical gauze must meet standards of purity, thread count,construction, and sterility. The particular type of gauze can be wovenor nonwoven, sterile or non-sterile, plain or impregnated withpharmaceutical materials, and can be available in various thicknesses.Woven gauze has a loose, open weave, which allows fluids to be absorbedinto the fibers. Most woven products are a fine or coarse cotton mesh.Nonwoven gauze consists of fibers pressed together, which providesimproved wicking and greater absorbent capacity. Compared to wovengauze, this type of gauze produces less lint and has the benefit ofleaving fewer fibers behind in a wound when removed. Most nonwoven gauzeis made of polyester, rayon, or blends of these fibers and is stronger,bulkier, and softer than woven pads. Both woven and nonwoven gauze padsare useful for blood absorbency.

In alternative embodiments, illustrated in FIG. 7 and FIG. 8, theinventive retractor can be used without the absorbent pad or panel 20.For example, in addition to providing improved exposure and enhancedvisualization of an episiotomy or vaginal laceration, improved vaginalretractors are needed for other gynecological procedures to help thesurgeon visualize, inspect, repair and/or remove a portion of the lowerinternal genital organs. Common gynecological procedures and surgeriesthat could benefit from an improved vaginal retractor include, but arenot limited to, loop electrosurgical excision procedure (LEEPprocedures), uterine manipulator placement for laparoscopic/robotichysterectomies, colposcopies, D&C procedures, cervical biopsies, and PAPtests.

Typically a vaginal speculum is used during such a gynecologicalprocedure, being introduced into a patient's vagina to separate thevaginal walls and allow the lower internal genital organs to beexamined. Metal, autoclavable duck-bill specula are conventionally usedfor such procedures. These units, with exposed joints, sharp edges, andcold metal are universally disliked by patients. The hinged joints andblade edges often pinch, scrape, or otherwise traumatize the delicate,supporting tissues in the area being examined. The conventional metallicspecula blades are typically opaque, so that the only area available forinspection with a metallic speculum is the open end, for cervicalexamination, and the vaginal wall areas between the blades.

In an attempt to eliminate such problems, the vaginal retractorembodiments shown in FIGS. 7-8 can be used for gynecological proceduressuch as those listed above, and can be particularly useful for LEEPprocedures and uterine manipulator placement for laparoscopic/robotichysterectomies. A LEEP procedure is performed by a surgeon to removeabnormal tissue from the cervix. It may be done to confirm a cancerdiagnosis or treat precancerous conditions of the cervix. During a LEEP,a thin wire loop is used to excise abnormal tissue. The cervix is thencauterized to stop any bleeding, and the remaining area usually heals in4 to 6 weeks. Uterine manipulators are frequently preferred inlaparoscopic hysterectomy because they reduce the incidence of ureteralinjuries and facilitate colpotomy (an incision in the back wall of thevagina). In addition, uterine manipulators are used in diagnosticprocedures that require the anteroposterior and lateral movements of theuterus, tubal ligation, and laparoscopic excision of ovarian masses anduterine fibroids. As a result, uterine manipulators are frequently usedin many operative or diagnostic gynecological laparoscopic proceduresbecause they are thought to reduce complications by facilitatingdissection and increasing the field of view of the surgeon.

Like the retractor illustrated in FIGS. 1-6, the retractor embodimentsshown in FIGS. 7 and 8 include a frame 112 for positioning within thevaginal canal. The frame 112 is defined by an upper support 113, a lowersupport 115, a right lateral support 117, and a left lateral support119. The supports are preferably connected at their ends to form afour-sided frame 112 defining a central aperture 120 within its innerperimeter. The frame 112, as illustrated, is biased in the open positionand the supports 113, 115, 117, 119 are oriented substantially in asingle plane. However, unlike the previous embodiments described above,the central aperture 120 illustrated in FIG. 7 and FIG. 8 is not spannedor otherwise covered by a panel (20, see, e.g., FIG. 5). With physicalaccess through the central aperture 120 of the frame, the user isprovided with improved exposure and visualization of the internal femalelower reproductive system, and a wire loop or uterine manipulator caneasily be passed.

Each of the four corners of the frame 112 of FIGS. 7 and 8 haveprojections, specifically, a right upper anterior stability post 140, aleft upper anterior stability post 142, a right lower anterior stabilitypost 144, and a left lower anterior stability post 146. The anteriorstability posts 140, 142, 144, 146 extend substantially perpendicularlyfrom the plane of the open frame 112, and are preferably made of a rigidplastic material similar to or the same as the frame supports 113, 115,117, 119. The frame supports and the anterior stability posts functionto support and retract the vaginal tissues during use, so that the usercan visualize the cervix, uterus, vaginal walls, etc. through thecentral aperture 120. To provide a wider base and more stability to theframe when inserted past the introitus and deeper into the vaginalcanal, the lower anterior stability posts 144 and 146 can be longer andthus extend farther out from the plane of the frame 112 than the upperanterior stability posts 140, 142, as illustrated in FIG. 7 and FIG. 8.In addition, the distal ends of the lower anterior stability posts 144,146 can be outwardly curved or otherwise biased in an outward directionto help prevent the lateral vaginal walls from obscuring the centralaperture. The angle of the outward curve can be between about 10 degreesand about 90 degrees, and is illustrated at about a 45 degree angle.This curved design of the lower anterior stability posts 144, 146 canprovide more stability to the frame when inserted, giving the retractoran improved ability to restrain the lateral and posterior vaginal wallsfrom obscuring the view through the central aperture 120.

The embodiments of FIG. 7 and FIG. 8 also include a plurality of wallsin the form of plastic barriers, sheets, nets, or webbings,specifically, a right side wall 150, a left side wall 152 and an upperwall 154. FIG. 8 also shows a lower wall 156. Each of the walls 150,152, 154, 156 is generally quadrilateral in shape, connected at three ofits sides to the frame, and extends substantially perpendicularly fromthe plane of the open frame. As illustrated, the right side wall 150extends between the right upper anterior stability post 140 and theright lower anterior stability post 144. The right side wall 150 has onefree side 151, i.e. a side not connected to the frame, with the threeremaining sides respectively connected to the lengths of the rightlateral support 117, the right upper anterior stability post 140, andthe right lower anterior stability post 144. The left side wall 152extends between the left upper anterior stability post 142 and the leftlower anterior stability post 146, and having one free side 153 with thethree remaining sides respectively connected to the left lateral support119, the left upper anterior stability post 142, and the left loweranterior stability post 146.

The upper wall 154 as illustrated extends between the right upperanterior stability post 140 and the left upper anterior stability post142, including one free side 155 with the three remaining sidesrespectively connected to the upper support 113, the right upperanterior stability post 140, and the left upper anterior stability post142. The right side wall 150 and left side wall 152 provide additionalmeans, by way of additional vaginal sidewall retraction, for the frame112 to restrain or otherwise hold back vaginal or labial tissues fromobscuring or obstructing the user's view through the central aperture120. Similarly, the upper wall 154 can provide retraction of tissuessuch as the anterior vaginal wall. Like the extended lower stabilityposts, the walls can provide more stability to the frame when insertedpast the introitus and deeper into the vaginal canal, and can preventthe vaginal walls from obscuring the central aperture

The embodiment in FIG. 8 is similar to that of FIG. 7, but furtherincludes the lower wall 156. As illustrated, the lower anteriorstability posts 144, 146 can project straight outward, without thedistal curves of the embodiment shown in FIG. 7. The lower wall 156extends between the right lower anterior stability post 144 and the leftlower anterior stability post 146 and allows the retractor to hold backtissues of the posterior vaginal wall from obscuring the user's viewthrough the central aperture 120. Similar to the embodiment of FIG. 7,the embodiment of FIG. 8 also includes a right side wall 150, a leftside wall 152 and an upper wall 154, as described above. When the frame112 is in the closed or collapsed position, the right and left sidewalls 150, 152 can remain substantially straight or rigid when theretractor is folded, but the upper wall 154 and lower wall 156 should bemade of a material that is forgiving enough so that it can fold orotherwise bias inward towards the center of the frame when the frame isfolded (upper wall 154 folds down, and lower wall 156 folds up), so thatthey do not obstruct the retractor during insertion.

The embodiments illustrated in FIGS. 7 and 8, while specificallydesigned for deeper placement into the vaginal canal, can be used forany gynecological procedures involving the lower internal genitalorgans. More specifically, the inventive device as illustrated in FIGS.7-8 can be manufactured to include an absorbent pad 20 (as described forFIGS. 1-6, above) spanning the central aperture. This can be useful forabsorbing blood and other fluids during a vaginal repair. As anon-limiting example, if an episiotomy laceration in the posteriorvaginal wall needs to be repaired, an absorptive gauze panel 20 asdescribed earlier herein can be attached to the frame illustrated inFIG. 7 to cover the central aperture 120. Since this retractor includesside walls 150, 152 and upper wall 154 but no lower wall, it providesexcellent exposure of the lacerated posterior vaginal wall. In contrast,the retractor illustrated in FIG. 8, having four walls 150, 152, 154 and156 and an open central aperture 120 can be more useful for allowing thesurgeon to view and surgically access the interior of the vagina duringa LEEP procedure. In such a procedure, inclusion of a frame with thefourth, lower wall 156 as illustrated in FIG. 8 can be useful forrestraining the posterior vaginal wall from obscuring the user's viewthrough the central aperture 120.

The frame supports 113, 115, 117, 119 of the embodiments illustrated inFIGS. 7 and 8 preferably have a thickness and/or width which preventsfailure of the frame when in the open position, i.e. failure of thesupports that may be caused by the application of lateral pressure orstress exerted by the vaginal walls during a gynecological procedure. Asnoted above, the frame 112 is biased or predisposed to assume anexpanded or open position, but can be folded or otherwise manuallycompressed or collapsed by a user into a closed position (see, e.g.,FIGS. 3A and 3B). Both the upper support 113 and the lower support 115include bendable central crimps 114 and 116 made of a plastic orelastomer which is less rigid in nature than the frame supports.Nevertheless, the stiffness of the crimps can be such that bending ofthe crimps 114, 116 only occurs when a certain manual force is appliedto overcome the resistance provided by the crimps. For example,preferably the crimps are made of a semi-rigid but flexible plasticmaterial that will not bend under the lateral pressure forces of thevaginal walls, yet can be caused to bend when a directed force isapplied by the user.

The crimps 114, 116 can be of soft to medium hardness (e.g. 35-60 ShoreA) so that they can be bendable but, as noted above, biased tostraighten out and to return the frame to a substantially openconfiguration, while the supports 113, 115, 117, 119 and stability posts140, 142, 144, 146 can be comparatively more rigid, measuring on thehigh end of the hardness scale (e.g. 75-100 Shore A). Each of the websor walls 150, 152, 154, 156 illustrated in FIGS. 7 and 8 can be made ofa material similar to that of the crimps 114, 116, so that they areflexible yet strong enough to resist vaginal wall pressures.

The present invention provides an improved apparatus and method forperforming a vaginal repair which improves access and visualization ofthe repair site, is configured to minimize slippage during use, andwhich is lightweight and minimizes discomfort to the patient. It alsoprovides a means to absorb or prevent blood/fluids entering the surgicalfield, is inexpensive to manufacture and maintain, and can be utilizedby health care professionals having various skill levels. While thepresent invention has been illustrated by the description of particularembodiments in considerable detail, it is not intended to restrict orlimit the scope of the appended claims to such detail. Additionaladvantages and modifications will be readily apparent to those skilledin the art without departing from the concept or scope of the invention.

What is claimed is:
 1. A retractor for gynecological proceduresinvolving the lower internal genital organs, the retractor comprising:a) a frame defining a central aperture, the frame including an uppersupport, a lower support, a right lateral support, a left lateralsupport, a right upper anterior stability post, a left upper anteriorstability post, a right lower anterior stability post, and a left loweranterior stability post, wherein the frame is biased to assume an openposition in which the supports are oriented substantially in a singleplane, and wherein each of the anterior stability posts extendsubstantially perpendicularly from the plane of the open frame; and b) aplurality of walls for restraining vaginal tissues from obstructing thecentral aperture, wherein each of the plurality of walls is connected tothe frame and extends substantially perpendicularly from the plane ofthe open frame, and wherein the frame can be folded into a closedposition for insertion into the vaginal canal.
 2. The retractor of claim1, wherein the lower anterior stability posts are longer than and extendfarther out from the plane of the frame than the upper anteriorstability posts.
 3. The retractor of claim 1, wherein the lower anteriorstability posts are outwardly curved.
 4. The retractor of claim 1,wherein the plurality of walls comprises: a) a right side wall locatedbetween the right upper anterior stability post and the right loweranterior stability post; b) a left side wall located between the leftupper anterior stability post and the left lower anterior stabilitypost; and c) an upper wall located between the right upper anteriorstability post and the left upper anterior stability post.
 5. Theretractor of claim 4, wherein the right side wall is connected to theframe at the right lateral support, the right upper anterior stabilitypost, and the right lower anterior stability post, wherein the left sidewall is connected to the frame at the left lateral support, the leftupper anterior stability post, and the left lower anterior stabilitypost, and wherein the upper wall is connected to the frame at the uppersupport, the right upper anterior stability post, and the left upperanterior stability post.
 6. The retractor of claim 4, wherein theplurality of walls further comprises: i) a lower wall located betweenthe right lower anterior stability post and the left lower anteriorstability post, wherein the lower wall is connected to the frame at thelower support, the right lower anterior stability post, and the leftlower anterior stability post.
 7. The retractor of claim 1, furthercomprising a compliant panel spanning the central aperture.
 8. Theretractor of claim 6, wherein the compliant panel is an absorbent padmade of a semi-permeable material useful for absorbing blood and otherfluids.
 9. The retractor of claim 1, wherein the lower support, theright lateral support, and the left lateral support are substantiallythe same length, and wherein the upper support is shorter in length thanthe lower support, so that the overall shape of the frame is trapezoidalwhen in the open position.
 10. The retractor of claim 1, wherein theupper support includes a central upper crimp and the lower supportincludes a central lower crimp, the crimps being biased to bend when aforce is applied by the user and to straighten when the force isreleased.
 11. The retractor of claim 1, wherein the right lateralsupport and the left lateral support include raised semi-circular ridgesprotruding from the outer circumference of the lateral supports toreduce slippage of the frame within the vaginal canal.
 12. A retractorfor gynecological procedures involving the lower internal genitalorgans, the retractor comprising: a) a frame defining a centralaperture, the frame including: i) an upper support including a centralupper crimp; ii) a lower support including a central lower crimp,wherein the central upper crimp and the central lower crimp are biasedto bend when a force is applied by a user and to straighten when theforce is released; iii) a right lateral support; iv) a left lateralsupport, wherein the upper support, the lower support, the right lateralsupport, and the left lateral support are connected to form the framedefining the central aperture; v) a right upper anterior stability post;vi) a left upper anterior stability post; vii) a right lower anteriorstability post; and viii) a left lower anterior stability post; whereinthe frame is biased to assume an open position in which the supports areoriented substantially in a single plane, and wherein each of theanterior stability posts extend substantially perpendicularly from theplane of the open frame; and b) a plurality of walls for restrainingvaginal tissues from obstructing the central aperture, wherein each ofthe plurality of walls is connected to the frame and extendssubstantially perpendicularly from the plane of the open frame, theplurality of walls comprising: i) a right side wall located between theright upper anterior stability post and the right lower anteriorstability post; ii) a left side wall located between the left upperanterior stability post and the left lower anterior stability post; andiii) an upper wall located between the right upper anterior stabilitypost and the left upper anterior stability post, wherein the frame canbe folded into a closed position for insertion into the vaginal canal.13. The retractor of claim 12, wherein the lower anterior stabilityposts are longer than and extend farther out from the plane of the openframe than the upper anterior stability posts.
 14. The retractor ofclaim 12, wherein the lower anterior stability posts are outwardlycurved.
 15. The retractor of claim 12, wherein the right side wall isconnected to the frame at the right lateral support, the right upperanterior stability post, and the right lower anterior stability post,wherein the left side wall is connected to the frame at the left lateralsupport, the left upper anterior stability post, and the left loweranterior stability post, and wherein the upper wall is connected to theframe at the upper support, the right upper anterior stability post, andthe left upper anterior stability post.
 16. The retractor of claim 12,the plurality of walls further comprising: iv) a lower wall locatedbetween the right lower anterior stability post and the left loweranterior stability post, wherein the lower wall is connected to theframe at the lower support, the right lower anterior stability post, andthe left lower anterior stability post.
 17. The retractor of claim 12,further comprising a compliant panel spanning the central aperture. 18.The retractor of claim 17, wherein the compliant panel is an absorbentpad made of a semi-permeable material useful for absorbing blood andother fluids.
 19. The retractor of claim 12, wherein the lower support,the right lateral support, and the left lateral support aresubstantially the same length, and wherein the upper support is shorterin length than the lower support, so that the overall shape of the frameis trapezoidal when in the open position.